BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4251885 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52686
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP EXCESSIVELY ALARMED NO DELIVERY. THE CALLER DID NOT KNOW THE BLOOD GLUCOSE READING. THE CALLER STATED THAT THERE HAD BEEN 8 NO DELIVERY ALARMS WITHIN 2 DAYS' SPAN. IT WAS NOTED THAT THE CUSTOMER HAD TO PERFORM INFUSION SET CHANGES AND THAT THE ALARMS WOULD HAPPEN THROUGHOUT THE NIGHT. THE SAME INFUSION SET WAS HOOKED UP AND NO ISSUES WERE NOTED IN THE LAST 24 HOURS. THE CALLER STATED THAT THE BATTERY AND INFUSION SETS WERE CHANGED BUT THE ALARMS PERSISTED. THE CALLER NOTED THAT ONE OF THE OPERATORS AT THE PEDIATRICIAN'S OFFICE ADVISED THAT THE ISSUE MAY BE SCAR TISSUE OR FATTY TISSUE AT THE INSERTION SITE; THE DOCTOR, HOWEVER, DID NOT REPORT ANY SCAR TISSUES OR ISSUES LIKE THAT. ADVISED THAT REPLACEMENT SUPPLIES WOULD BE SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737703 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LCAH

    Patients

    Seq Age Sex Outcome Treatment
    1 UNOMEDICAL INFUSION SET